Regulatory Startup Support Services

The CCTS Regulatory Knowledge and Support core can help investigators navigate the study start-up process by providing the following services:

  • 2 hour complimentary consultation

  • Assistance with IRB and/or FDA Submissions

  • Assistance with Protocol Development

  • Creation of Regulatory Binder

  • Assistance with Regulatory documents (i.e. 1572, Financial Disclosure, Site Signature, Delegation log, CV, Medical License, Laboratory certification, etc.)

  • Serve as a liaison with study sponsor


CCTS Regulatory Core Holiday Schedule

Please note the 2019 holiday schedule for CCTS Regulatory office:  

November 2019

•   Thursday, Nov. 28  (Thanksgiving Day) – Regulatory Unit Closed

•   Friday, Nov. 29 (day after Thanksgiving) – Regulatory Unit Closed

December 2019

•   Friday, Dec. 13th – the Regulatory Unit Closed after 1pm for a CCTS function  

•   Monday, Dec. 23 - Wednesday, Jan. 1 Regulatory Unit Closed (Reopening Thursday, Jan. 2)

Please note:

•   We realize this extended closure may be inconvenient for you and may affect your study schedules.   If you have questions, need further clarification, or if any of the above presents a problem to you or your research team, please contact Laura Ashe at (859) 323-2782 or no later than November 29, 2019. 

•   With the cold weather coming soon, we want you to be aware, that if the University announces planned delays or closures (Plan B), the regulatory unit will operate on the delayed schedule or will be closed.